Non-Invasive Measurement of GI Motility in Patients With ALS

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Philadelphia,
Pennsylvania19104

Purpose:

Recent evidence implicates abnormalities of autonomic function in ALS including problems
with gastrointestinal (GI) motility. GI complaints reported by ALS patients such as
constipation, diffuse abdominal pain, and a feeling of fullness or nausea may be attributed
to autonomic involvement. Toepfer et al. found delayed gastric emptying in most ALS
patients, indicating autonomic dysfunction (Gastrointestinal dysfunction in amyotrophic
lateral sclerosis. Amyotrophic Lateral Sclerosis Other Motor Neuron Disord 1999; 1:15—19).
The same authors also reported markedly prolonged colon transit time in ALS (Toepfer et al:
Delayed colonic transit times in amyotrophic lateral sclerosis assessed with radio-opaque
markers. Eur J Med Res 1997; 2:473—476).
The present study will investigate the GI transit time in a large cohort of patients and
controls using a noninvasive technique that measure hydrogen gas production with the
digestion of lactulose in a measured substrate load presented to the bowel.

Study summary:

This study will examine how much time it takes for the food to travel along the intestines
from mouth or stomach (if you have a feeding tube) to the end of the large intestine using a
special instrument that measures hydrogen gas in your breath. Data collection will start
after you sign this consent form. The only procedures that would be above and beyond routine
care are indicated below:
In order to prepare for the study you will be asked to be off all medications that affects
the GI motility for 24 hours. You will also be asked to fast overnight (starting midnight)
the day before the test.
After fasting overnight, the test will be performed in the morning (at the Neurology
Outpatient Clinic or at your home). Before eating or drinking anything a baseline
measurement will be taken by breathing into the hydrogen meter. This will be just normal
breathing. You will then drink a test meal consisting of 250 ml (approximately 1 cup) of a
lactose (type of sugar) free supplement (For example Ensure) that has 20 grams of Lactulose
added. If you have a peg tube then the supplement will be given through the tube. After 10
minutes you will again be asked to breath into the machine to measure the hydrogen gas
levels. This will be repeated every 10 minutes until the hydrogen levels rise to a certain
level or until 4 hours have passed.

Criteria:

Inclusion Criteria:
For the Disease Population:
- Diagnosis of definite or possible ALS by the El Escorial Criteria
- No previously known gastrointestinal problems
- Able to fast and hold medicines (anticholinergics and prokinetics) overnight prior to
the measurement of GI motility
- No unstable medical problems and no evidence of dehydration by examination (skin
turgor)
For Healthy Control
- No known gastrointestinal illness
- Able to fast and hold medicines (anticholinergics) overnight prior to the measurement
of GI motility
- No unstable medical problems or evidence of dehydration
Exclusion Criteria:
- Patients or controls who are dehydrated
- Patients or controls who have evidence of previous gastrointestinal disease
- Patients with any unstable medical condition
- Patients unable to give informed consent
- Patients unable to blow into the breath analyzer and have steady breathing for one
minute

NCT ID:

NCT00714805

Primary Contact:

Principal InvestigatorTerry D Heiman-Patterson, MDDrexel University College of Medicine

Backup Contact:

N/A

Location Contact:

Philadelphia, Pennsylvania 19104United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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